One of the 206 patients who received a radiation overdose eight times normal during a CT scan at Cedars-Sinai Medical Center, has filed a class action lawsuit against both the hospital and the device manufacturer, GE Healthcare Technologies.
The lawsuit alleges that the plaintiff, Trevor Rees, was not only subjected to an overdose of radiation, but faces a higher risk of cancer, expense of longer term health monitoring of its effects, and suffers "severe and serious physical and emotional damage." Rees actually underwent two scans, and potentially received the overdose twice.
The lawsuit also maintains that hospital officials who contacted Rees nine months later asked about whether he had experienced side effects, but did not tell him he had been overexposed.
"There was no mention of radiation to me on the phone at all," Rees said in a statement issued by his Los Angeles attorney, William Newkirk. "I never thought anything more about it until I saw the news about five days later."
The 19-page complaint, filed on behalf of Rees and Does 1-100, seeks to represent "all individuals who received CT brain perfusion scans at CSMC from February, 2008 until August, 2009, or at any other medical or imaging facilities utilizing CT imaging machines manufactured by GEHC/GEHCT, during the two-year period preceding this action." It was filed in Los Angeles Superior Court.
Newkirk said yesterday in a statement, "This isn't just a Cedars-Sinai problem. We believe that because of the way the machine is manufactured and explained to medical users, there is a very good chance that this same situation has been or is being played out in radiology departments across the country. We have no idea how many people have been overdosed with radiation."
It is not known whether other hospitals or healthcare facilities using the same GE scanners, identified as 64-slice CT machines, experienced overdoses of radiation. But the U.S. Food and Drug Administration said that it was launching a safety investigation that extended beyond Cedars-Sinai.
"While this event involved a single kind of diagnostic test at one facility, the magnitude of these overdoses and their impact on the affected patients were significant," the FDA said Oct. 8 in an initial notification notice. "This situation may reflect more widespread problems with CT quality assurance programs and may not be isolated to this particular facility or this imaging procedure (CT brain perfusion)."
In a statement, a GE Healthcare spokesman yesterday said the company is "aware of litigation regarding the incident at Cedars-Sinai" but is unable to comment on specifics.
"We remain concerned for the health of patients who may have received excess medical radiation at Cedars-Sinai Medical Center. GE Healthcare continues to cooperate with the Food and Drug Administration officials on this matter. Although GE Healthcare continues its internal investigation, we confirm that there were no malfunctions or defects in any of the GE Healthcare equipment involved."
GE's statement adds: "GE Healthcare continues to offer dose-reducing technologies and expand key CT training initiatives to raise awareness of dose optimization and use of appropriate exam protocols.
"GE Healthcare CT products require that:
"1) Users carefully evaluate user-defined scanning protocols against the validated protocols that are provided on the scanners during installation, and
"2) Like dose recommendations for drugs, the recommended dose for a prescribed medical imaging scan is an important clinical decision that should be made by a licensed professional in the context of healthcare delivery.
"Patients and families should continue to have confidence in their doctor's recommendation for a CT scan."
According to Rees' lawsuit, he underwent a perfusion CT imaging procedure at the S. Mark Taper Foundation Imaging Center on Dec. 22, 2008 in order to diagnose and evaluate a suspected stroke.
Two days later, he was informed that there had been a technical problem with the scan and a second one was needed, according to the lawsuit.
"In the days and weeks immediately following the two CT scans at CSMC, plaintiff experienced significant hair and eyebrow loss, flaking of the scalp and facial skin, skin reddening or burns on his scalp and various other indications of excessive radiation exposure."
Nine months later, in late September, Rees says he was contacted by CSMC personnel to inquire about his CT scan experience and was questioned about whether he had experienced side-effects, but was not told why.
"Plaintiff was not advised of any radiation overexposure or other problem regarding the CT scans he had received, nor was he provided any further information by CSMC," the lawsuit claims.
In his statement, Rees said, "I certainly don't relish the chance of dying of tumors. I'm supposed to live stress free and this hasn't helped matters." A spokeswoman for his attorney said Rees is 65.
The lawsuit asks for general damages, past and future economic damages including cost of medical care, monitoring and treatment, loss of earnings, and for lawsuit costs and attorneys' fees.
Cedars-Sinai officials did not return requests for comment on the lawsuit. But last week hospital president and CEO Tom Priselac released a statement recommending to the FDA that CT scanner manufacturers make four adjustments, such as adjusting the settings of the "auto" function, to prevent such errors from occurring.
"We present this information not to shift responsibility, but to maximize patient safety by involving manufacturers in the process of continually improving processes and equipment," Priselac wrote.
Meanwhile throughout the Web, law firm advertisements are beginning to proliferate. One recent ad advised: "Did you get a radiation overdose at Cedars-Sinai MC? Free consultation."
A Cedars-Sinai spokeswoman declined comment.